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NCT04323787 Clinical Trial

Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry

Coronavirus Clinical Trial

— COVID-19  

Official title:
Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04323787
Other study ID # 20-002610
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 30, 2020
Est. completion date March 31, 2025

Study information
Verified date April 2024
Source Mayo Clinic
Contact Rahul Kashyap, MBBS
Phone 5072557196
Email Kashyap.Rahul@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Researchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.

Description:

Investigators aim is to create a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals. Such a set of standards would increase the quality of single and multi-center studies, national registries as well as aggregation syntheses such as meta-analyses. It will also be of utmost importance in tiring times of public health emergencies and will help understand practice variability and outcomes during COVID-19 pandemic.

Recruitment information / eligibility
Status Recruiting
Enrollment 100000
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - COVID-19 PCR positive (within 7 days) - COVID-19 PCR pending - COVID-19 high clinical suspicion Exclusion Criteria: - Patient without Prior Research Authorization (applicable to Mayo Clinic sites) - Non COVID-19 related admissions - Repeated Admission to ICUs/Hospital

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• observational
No Intervention

Locations
Country Name City State
United States Society of Critical Care Medicine (150+ sites) Chicago Illinois
United States Mayo Clinic in Florida Jacksonville Florida
United States Rahul Kashyap Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (3)
Lead Sponsor Collaborator
Mayo Clinic Boston University, Society of Critical Care Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary ICU and hospital mortality of COVID-19 patients Primary outcome will be to measure ICU and hospital mortality up to 7 days of COVID-19 patients 7 days
Secondary 30 days mortality Secondary outcome will be to measure 30 days mortality from Hospital discharge 30 days
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